Patient SurvivalDR-MM in LTNCT07250919
Donor and Recipient Mismatch in Liver Transplantation
An observational study of Patient Survival and Graft Survival, run by University of Jena at 1 site in Canada.
Trial summary
This observational study aims to investigate the impact of gender disparity between donors and recipients on long-term outcomes after liver transplantation (LT). The study aims to answer the following question: Does gender mismatch lower the possibility of survival after liver transplantation? Participants demonstrate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Survival, Graft Survival, Liver Disease (Alcoholic or Not)
- How many people
- 1,146 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2014to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent liver transplantation at who at the Ajmera transplant centre, Toronto between 2014 and 2022
Who may be able to join
- Patients over the age of 18
Who cannot join
- Cases of retransplantation
- Combined organ transplantation
- Cases with >30% of missing values
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ajmera Transplant Centre, Toronto General Hospital, University Health Network, Toronto
Toronto, Ontario
About this study
Official title: Donor and Recipient Mismatch in Liver Transplantation - Time for Reconsideration?
This observational study aims to investigate the impact of gender disparity between donors and recipients on long-term outcomes after liver transplantation (LT). The study aims to answer the following question:
Does gender mismatch lower the possibility of survival after liver transplantation? Participants demonstrate gender dicrepancies between donors and recipients as regular concept in LT. The retrospective cohort study investigates the impact over a long-term follow up of 10 years.
Read the detailed description
The study involves patients who undergo liver transplantation at the Ajmera Transplant Centre Toronto from 2014 until 2022. The observation period ended at the first January 2025 to provide a minimal follow up of 24 months.
Liver transplant recipients with gender mismatch (A) will be compared with liver transplant recipients without gender mismatch (B).
Liver transplantation is the only curative treatment for people with end stage liver disease. Gender mismatch between donor and recipient, particularly, the combination of a female donor to male recipient has been controversial in the past. Identifying risk factors that could affect the survival of the graft and recipient is of the utmost importance.
- Conditions
- Patient Survival, Graft Survival, Liver Disease (Alcoholic or Not), Liver Transplant Surgery
- Keywords
- liver transplantation, patient survival, gender mismatch, long-term outcome, organ allocation
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GM + | Liver transplant recipients with gender mismatch | |
| GM - | Liver transplant recipients without gender mismatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Overall survival of patients who underwent liver transplantation at the Ajmera transplant centre toronto between 2014 and 2022
Measured: Liver transplantation between 01.01.2014 and 01.01.2022, Patient Survival: observatory period between 01.01.2014 and 01.01.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2014
- Primary completion1 Jan 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Nicola Sariye Pollmann, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250919
- Sponsor's protocol ID
- 20-5877.4
- Acronym
- DR-MM in LT
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators consider not to share IPD before publishing the study.
Publications
Ghinolfi D, Melandro F, Torri F, Martinelli C, Cappello V, Babboni S, Silvestrini B, De Simone P, Basta G, Del Turco S. Extended criteria grafts and emerging therapeutics strategy in liver transplantation. The unstable balance between damage and repair. Transplant Rev (Orlando). 2021 Dec;35(4):100639. doi: 10.1016/j.trre.2021.100639. Epub 2021 Jul 16.
PubMed 34303259
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor and Recipient Mismatch in Liver Transplantation - Time for Reconsideration?
- ClinicalTrials.gov ID
- NCT07250919
- Acronym / sponsor ID
- DR-MM in LT / 20-5877.4
- Conditions
- Patient Survival, Graft Survival, Liver Disease (Alcoholic or Not), Liver Transplant Surgery
- Keywords
- liver transplantation, patient survival, gender mismatch, long-term outcome, organ allocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to investigate the impact of gender disparity between donors and recipients on long-term outcomes after liver transplantation (LT). The study aims to answer the following question:
Does gender mismatch lower the possibility of survival after liver transplantation? Participants demonstrate gender dicrepancies between donors and recipients as regular concept in LT. The retrospective cohort study investigates the impact over a long-term follow up of 10 years.
Detailed description
The study involves patients who undergo liver transplantation at the Ajmera Transplant Centre Toronto from 2014 until 2022. The observation period ended at the first January 2025 to provide a minimal follow up of 24 months.
Liver transplant recipients with gender mismatch (A) will be compared with liver transplant recipients without gender mismatch (B).
Liver transplantation is the only curative treatment for people with end stage liver disease. Gender mismatch between donor and recipient, particularly, the combination of a female donor to male recipient has been controversial in the past. Identifying risk factors that could affect the survival of the graft and recipient is of the utmost importance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GM + | – | –Liver transplant recipients with gender mismatch |
| GM - | – | –Liver transplant recipients without gender mismatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver transplantation at who at the Ajmera transplant centre, Toronto between 2014 and 2022
Key inclusion criteria (1 listed)
- Patients over the age of 18
Key exclusion criteria (3 listed)
- Cases of retransplantation
- Combined organ transplantation
- Cases with >30% of missing values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient survival
Time frame: Liver transplantation between 01.01.2014 and 01.01.2022, Patient Survival: observatory period between 01.01.2014 and 01.01.2024
Overall survival of patients who underwent liver transplantation at the Ajmera transplant centre toronto between 2014 and 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 34303259Ghinolfi D, Melandro F, Torri F, Martinelli C, Cappello V, Babboni S, Silvestrini B, De Simone P, Basta G, Del Turco S. Extended criteria grafts and emerging therapeutics strategy in liver transplantation. The unstable balance between damage and repair. Transplant Rev (Orlando). 2021 Dec;35(4):100639. doi: 10.1016/j.trre.2021.100639. Epub 2021 Jul 16.
- Individual participant dataSharing planned: Undecided. The investigators consider not to share IPD before publishing the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Survival and Graft Survival, run by University of Jena at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: Liver transplantation between 01.01.2014 and 01.01.2022, Patient Survival: observatory period between 01.01.2014 and 01.01.2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.